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Completed

NCT Number: NCT03588897

The Impact of Oral Nutritional Supplements on the Nutritional Status of Elderly Patients

The study compares nutritional status of two groups elderly patient aged 65 and more. One group of the patients received nutritional support (Nutridrink Multi Fibre) for 14 days. Nutritional status of the patients were compared 2 months after the start of the intervention.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

The aim of the study was to compare nutritional status of two groups of elderly patients (> 65 years old). Total of 120 patients were randomly assigned into two groups. One group received normal diet whereas the second group received 300 kcal nutritional support (Nutridrink Multi Fibre 2x100 ml) between meals for 14 days. Two months after start of the intervention following examinations were performed:

  • functional status of the patient (Barthel's scale, MMSE scale)
  • nutritional status based on: weight, height, BMI; Mini Nutritional Assessment, plasma concentration of prealbumin, albumin, transferrin, total lymphocyte count.

The clinical status of the patient was evaluated based on clinical data on different organ infections. In addition costs of supplementary nutrition were taken into consideration.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age > 65 and general status which enables compliance with study requirements
  • Barthel's scale (Barthel scale = Barthel ADL index - an ordinal scale used to measure performance in activities of daily living) points 21-100
  • MMSE (Mini Mental State Examination) points 24-30
  • no use of laxatives

Exclusion criteria

  • lack of consent
  • neoplasms
  • previous enteral nutrition
  • Barthel's scale 0-20
  • MMSE points 0-23
  • BMI > 25
  • laxatives

Treatment and study plan

Nutridrink Multi Fibre

Dietary Supplement

Dietary supplementation of 300 kcal for 14 days

Primary outcomes

  1. BMI of the elderly patients

    Time frame: 2 months

    BMI two months after start of the intervention

  2. Prealbumin plasma concentration

    Time frame: 2 months

    Prealbumin concentration two months after start of the intervention

  3. Albumin plasma concentration

    Time frame: 2months

    Albumin concentration two months after start of the intervention

  4. Transferrin plasma concentration

    Time frame: 2 months

    Transferrin concentration two months after start of the intervention

  5. TLC

    Time frame: 2 months

    Total lymphocyte count two months after start of the intervention

Secondary outcomes

  1. Organ infections

    Time frame: 2 months

    Infection in any organ based on clinical data

  2. Complications

    Time frame: 2 months

    Any complications associated with nutritional support

  3. Functional status of the patient - Barthel's scale

    Time frame: 2 months

    Scores in Barthel's scale two months after start of the intervention

  4. Functional status of the patient - MMSE scale

    Time frame: 2 months

    Scores in MMSE scale two months after start of the intervention

Sponsors and collaborators

Lead sponsor

Radoslaw Pach, MD, Ph D

Other

Registry information

Official study title

The Impact of Oral Nutritional Supplements on the Nutritional Status of the Elderly - Randomised Clinical Trial.

Important dates

Study start
2014
Primary completion
2016
Study completion
2018
First posted
Jul 17, 2018
Registry last updated
Jul 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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